Managing Side Effects of High-Dose Vardenafil

Erectile function (EF) domain score of the International Index of Erectile Function was estimated as the primary efficacy parameter. Results: Vardenafil 10 and 20 mg both significantly improved the EF domain score from 13.6 and 13.9 at baseline to 21.8 and 22.9 at last observation carried forward (LOCF), respectively, compared to placebo (13.7 at baseline to 16.3 at LOCF; p<0.0001).

What happens if I miss a dose?

It is not possible to determine whether these events were related directly to the use of PDE5 inhibitors or to other factors. Inform patients of the increased risk of NAION in individuals who have already experienced NAION in one eye and discuss the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including vardenafil, for this uncommon condition. Advise patients to stop treatment and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.

How is vardenafil supplied (dosage forms)?

The use of vardenafil offers no protection against sexually transmitted diseases. Counseling of patients about protective measure necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. Advise patients that the disintegrating tablet (Staxyn) is not interchangeable with the film-coated tablet (Levitra). General Notes: May be taken with or without food. (Tablet) Place on tongue to disintegrate; take without liquid and immediately upon removal from blister.

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Take once daily as needed, about 1hr before sexual activity. Moderate hepatic impairment: initially 5mg; max 10mg. Cardiovascular disease (eg, MI, stroke or life-threatening arrhythmia within 6 months; systolic BP <90mmHg or BP >170/110mmHg; unstable angina, LV outflow obstruction, severe heart failure), severe hepatic impairment, on renal dialysis, hereditary degenerative retinal disorders and retinitis pigmentosa: not recommended. History of non-arteritic anterior ischemic optic neuropathy (NAION) or those with "crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. In addition, vardenafil 20 mg demonstrated superior efficacy to 10 mg (p<0.05), and the difference was more evident in severe ED patients (baseline EF domain score <11).

The safety profile was comparable between these two doses (drug-related adverse events: 6.6, 22.0 and 24.2% in placebo, vardenafil 10 mg, and 20 mg arms, respectively).

The most common adverse events were hot flush, headache and nasal congestion, which were mild in intensity and transient, and are known to be common to PDE5 inhibitors. Conclusion: In Japanese men with DM and ED, vardenafil 10 mg and 20 mg were effective in improving erectile function with comparable safety profiles.

• Vardenafil is not a cure for erectile dysfunction, only a symptom treatment.
• Men with liver or kidney disease should inform their doctor before use.
• Do not take vardenafil if you have a recent history of stroke or heart attack.
• Follow the dosing schedule to minimize the risk of side effects.

Vardenafil 20 mg demonstrated superior efficacy compared with 10 mg, suggesting incremental clinical benefit in using the higher dose in this difficult-to-treat population.

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Patients for whom sexual activity is inadvisable or contraindicated. Mean steady-state volume of distribution: 208 L. Additive hypotensive effects with concomitant α-blockers, other antihypertensives; caution. Concomitant other erectile dysfunction treatments: women libido pills not recommended. Formerly known under the brand name Levitra.

How generics and brand-name Levitra differ

Aim: Vardenafil is a highly selective and potent phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). The efficacy of vardenafil has been demonstrated in a broad range of ED populations, but has not yet been assessed in Japanese patients with diabetes mellitus (DM), although DM is frequently associated with difficult-to-treat ED. This is the first study to investigate whether high-dose vardenafil (20 mg) can demonstrate superior efficacy to the usual dose (10 mg) in this subpopulation in Japan. Methods: The study was a randomized, placebo-controlled, double-blind, multi-centre, parallel group comparison 12-week study. Following 4 weeks observation period, 778 patients aged 26-64 years old with ED and DM (HbA1c >12% at screening was excluded) both of more than 3 years duration were randomly allocated to one of the three groups, vardenafil 10 mg, 20 mg, or placebo (randomization ratio 3:3:1). Vardenafil is used to treat men with erectile dysfunction (sexual impotence). It belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors.

These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly.

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This metabolite shows a phosphodiesterase selectivity profile similar to that of vardenafil and an in vitro inhibitory potency for PDE5 28% of that of vardenafil. Therefore, M1 accounts for approximately 7% of total pharmacologic activity. Elimination: The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91-95% of administered oral dose) and to a lesser extent in the urine (approximately 2-6% of administered oral dose). Pediatrics: Vardenafil is not indicated for use in pediatric patients.

Clin. Endocrinol. (Oxf)

Vardenafil trials were not conducted in the pediatric population. Geriatric: In a healthy volunteer study of elderly males (≥65 years) and younger males (18-45 years), mean Cmax and AUC were 34% and 52% higher, respectively, in the elderly males. Hepatic Impairment: In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. In volunteers with moderate hepatic impairment (Child- Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment.

What is Levitra

Renal Impairment: In male volunteers with ClCr= 50-80 mL/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with ClCr >80 mL/min. In male volunteers with ClCr = 30-50 mL/min or ClCr <30 mL/min renal impairment groups, the AUC of vardenafil was 20-30% higher compared to that observed in a control group with ClCr >80 mL/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis. Advise patients of the contraindication of vardenafil with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of vardenafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. The penis is one of the areas where this enzyme works.

• Combining vardenafil with other ED medications is not recommended.
• Side effects like vision changes are rare but should be reported.
• It may take several attempts to find the correct dose for optimal effect.
• Regular monitoring is advised if using vardenafil frequently.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection.

When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection.

Vardenafil dosing information

Inform patients of the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors. Inform patients that in some patients concomitant use of PDE5 inhibitors, including vardenafil, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients prescribed vardenafil who are taking alpha-blockers should be started on the lowest recommended starting dose. Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with vardenafil are prescribed by another healthcare provider.

Professional resources

Discuss with patients the appropriate use of vardenafil and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking vardenafil. It should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of vardenafil especially regarding the maximum daily dose. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with vardenafil or in the case of an unwanted effect.

How Long Do They Last?

Inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater erection tablets than 6 hours in duration) for vardenafil and this class of compounds. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Advise patients to stop treatment and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. By controlling the enzyme, avanafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, avanafil will not work to cause an erection.

• Vardenafil can cause side effects like headaches and flushing.
• It should not be taken with nitrate medications due to risk of blood pressure drop.
• Alcohol can increase side effects when combined with vardenafil.
• Consult a doctor before starting vardenafil to check for contraindications.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.

• The medication's effects typically last for 4-6 hours.
• Vardenafil is available by prescription only in most countries.
• Do not exceed the prescribed dose to avoid adverse effects.
• Store vardenafil in a cool, dry place away from children.